DepressionCMIDNCT05016388
Collaborative Multidimensional Intervention for Depression in Chile
A study testing Collaborative Multidimensional Model (CMD) and Standard Model (SM) in people with Depression, run by University of Talca.
Trial summary
This study protocol aims to determine the efficacy of a collaborative multidimensional model (CMD) to improve the results of depression in primary care (PHC) in Chile. The CMD includes training of PHC teams, on the recognition of clinical, functional and psycho-biographic dimensions associated to a complex depression… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Collaborative Multidimensional Model (CMD) and Standard Model (SM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 394 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2021to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Starting the treatment for depression in Primary Care according the Health Guarantees.
- Confirmed depression diagnosis according to the Mini International Diagnostic Interview Mini International Neuropsychiatric Interview (MINI, Sheehan et al. 1998).
Who cannot join
- Sensory disability
- Inability to provide the informed consent
- not having contact phone number
- Continuing treatment for depression
- High suicidal risk
- Suspected bipolar and psychosis.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of the Efficacy of a Multidimensional Collaborative Model to Improve the Resolution of Depression in Primary Care Teams in the Maule Region
This study protocol aims to determine the efficacy of a collaborative multidimensional model (CMD) to improve the results of depression in primary care (PHC) in Chile. The CMD includes training of PHC teams, on the recognition of clinical, functional and psycho-biographic dimensions associated to a complex depression sub-type, difficult to treat, prevalent in PHC in Chile, for which there are no recommendations in current clinical guidelines. This model implies the implementation of a collaborative model, trauma informed care, patient- centered, that includes a case manager, the use of instruments and a close relationship between the PHC team and the specialty level. At least twelve primary care teams belonging to the Maule Region will be randomly assigned to one of the two arms of the study, the CMD group and the current standard model (SM). After the implementation of the CMD, an intentional sample of 394 participants who agreed to participate, with prior informed consent, will be evaluated by a blind research team at the beginning, at three and six months with a battery of instruments. An improvement in depressive symptoms, anxiety and functional variables is expected in participants treated in CMD versus SM. This protocol was approved by the Research Ethics Council of the University of Talca, Talca. The goal is to publish the preliminary results in December 2022.
Read the detailed description
The research design is a cluster randomized clinical trial. Inter-professional teams from at least 12 primary care centers of the Maule area will be randomized in two arms: intervention and control. The intervention arm will receive a training in the collaborative multidimensional model for depression (CMD) and the control arm will be trained in the current clinical guide (SM).
After the CMD implementation, a sample of 394 participants entered to treatment for depression at their respective center will be invited to participate. This sample has been calculated estimating a maximum error of 5 %, a confidence level of 95 %, a power of 80 % a maximum variance of 50 % and a retention of 85 %.
The patients who agreed to participate, will be treated by their respective PHC team and their therapeutic indications will be included in the official clinical records for each participant. Also these patients, after informed consent, will be evaluated by a blind external research team at the beginning, at three and six months with a battery of instrument.
The informed consents will be kept in locked folders. The data obtained by the external evaluators will be confidential, entered into a virtual spreadsheet in a coded form on a server of the U. of Talca through a personal computer. Participant's diagnoses will be coded using the MINI.
A protocol for the management of adverse situations of an emergency nature will be provided.
The results will be presented according to the CONSORT guide for randomized clinical trials, with its extensions to cluster and non-pharmacological interventions.
Analysis of the primary and secondary outcomes will be performed by intention to treat. In the initial analysis, the balance between the characteristics of the different samples will be evaluated and a linear multi-variable regression will be performed to establish differences at 3 and 6 months, adjusting the results according to the initial data, in case of imbalance for all outcomes. A sensitivity analysis based on different assumptions will also be implemented, to investigate the possible effects of missing data. Statistical analysis will be done with SPSS software.
The research protocol was approved by the Ethics Committee of the University of Talca and approved by the Agencia Nacional de Investigación y Desarrollo (ANID), the national institution that audit the project through a follow-up sheet and yearly controls.
- Conditions
- Depression
- Being tested
- Collaborative Multidimensional Model (CMD), Standard Model (SM)
- Keywords
- Complex Depression, Collaborative Model, Primary Health Care, Trauma Informed Care, Difficult to treat Depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative Multidimensional Model (CMD)Other
Also called Intervention
The teams enrolled in the CMD intervention will have a 22-hour training that integrates current knowledge of depression with skills for the management of functional variables, interpersonal, social, emotional regulation, and history of biographical adversity from childhood considering the trauma informed care paradigm. After the training, the PHC teams will implement the depression treatment according to a collaborative model.
Standard Model (SM)Other
Also called Control
The teams enrolled in the SM intervention will have a 22-hour training that integrates the current national clinical guide for Depression in Chile. This guide offers a staggered treatment according to the severity of the depression. After the training, the PHC teams will implement the depression treatment according to the SM.
| Study group | Role | What they receive |
|---|---|---|
| Collaborative Multidimensional Model (CMD) | Experimental | The teams in the CMD group will be composed each of at least a MD, a psychologist, and a social worker. The teams will receive the CMD training and the CMD will be installed in the primary health care (PHC) center. Then, the participants with depression who enter treatment for depression in their respective PHC center, will be enrolled and evaluated by an external team, blind to the interventions at the beginning, three and six months after. Receives: Other: Collaborative Multidimensional Model (CMD) |
| Standard Model (SM) | Other | The teams in the SM group will be composed each of at least a MD, a psychologist, and a social worker. The teams will receive the SM training and the SM will be set in the primary health care (PHC) center. Then, the participants with depression who enter treatment for depression in their respective PHC center, will be enrolled and evaluated by an external team, blind to the interventions at the beginning, three and six months after. Receives: Other: Standard Model (SM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Depressive symptoms at three months relative to baseline
Depressive symptoms will be assessed by the Patient Health Questionnaire (PhQ9).
The Patient Health Questionnaire is a nine-item self-report measure that assesses the presence of depressive symptoms based on the DSM-IV criteria for major depressive. The Spanish version of the Patient Health Questionnaire has been validated in Chile.
The Patient Health Questionnaire measures the symptoms experienced by the patients during the two weeks prior to the interview.
Total score ranges from 0 to 27 points and greater scores means worse symptoms.
Measured: Three months after admission to depression treatment
Change in Depressive symptoms at six months relative to baseline
Depressive symptoms will be assessed by the Patient Health Questionnaire (PhQ9).
The Patient Health Questionnaire is a nine-item self-report measure that assesses the presence of depressive symptoms based on the DSM-IV criteria for major depressive. The Spanish version of the Patient Health Questionnaire has been validated in Chile.
The Patient Health Questionnaire measures the symptoms experienced by the patients during the two weeks prior to the interview.
Total score ranges from 0 to 27 points and greater scores means worse symptoms.
Measured: Six months after admission to depression treatment
Secondary outcomes (8)
Change in Anxiety symptoms at three months relative to baseline
Anxiety symptoms will be evaluated by the generalized anxiety scale-7 (GAD/7 validated in Spanish).
The generalized anxiety scale-7 serve as screening for generalized anxiety disorder.
The generalized anxiety scale-7 is a 7 Likert-type items with response options from 0 to 3 points .
A total score ranges from 0 to 21 points, greater scores means worse anxiety symptoms.
Measured: Three months after admission to depression treatment
Change in Anxiety symptoms at six months relative to baseline
Anxiety symptoms will be evaluated by the generalized anxiety scale-7 (GAD/7 validated in Spanish).
The generalized anxiety scale-7 serve as screening for generalized anxiety disorder.
The generalized anxiety scale-7 is a 7 Likert-type items with response options from 0 to 3 points .
A total score ranges from 0 to 21 points, greater scores means worse anxiety symptoms.
Measured: Six months after admission to depression treatment
Change in Interpersonal Dysfunction and Social Dysfunction at three months relative to baseline
Interpersonal and social areas will be evaluated by the sub-scales of the Outcome Questionnaire (OQ-45) interpersonal and social role.
The Outcome Questionnaire version 45-2 (OQ-45) is a self-administered instrument with evaluations in interpersonal and social role with Lkert-items whose response options range from 0 to 4 points.
The interpersonal subscale includes 12 items with scores that range from 0 to 48 points and the social scale includes 9 items with scores that range from 0 to 36 points. Greater score means worse Interpersonal and social function.
Measured: Three months after admission to depression treatment
Change in Interpersonal Dysfunction and Social Dysfunction at six months relative to baseline
Interpersonal and social areas will be evaluated by the sub-scales of the Outcome Questionnaire (OQ-45) interpersonal and social role.
The Outcome Questionnaire version 45-2 (OQ-45) is a self-administered instrument with evaluations in interpersonal and social role with Likert-items whose response options range from 0 to 4 points.
The interpersonal subscale includes 12 items with scores that range from 0 to 48 points and the social scale includes 9 items with scores that range from 0 to 36 points. Greater score means worse Interpersonal and social function.
Measured: Six months after admission to depression treatment
Change in Emotion Regulation at three months relative to baseline
Difficulties in Emotion regulation will be evaluated by the Emotion Regulation Scale (ERS) validated in Chile.
The Emotion Regulation Scale assesses emotions with respect to control, rejection, inattention, interference, and confusion.
ERS scale consists of 28 items with a Likert-type response options from 1 to 5 points, the scores range from 0 to 140 points and greater scores indicate worse emotional regulation.
Measured: Three months after admission to depression treatment
Change in Emotion Regulation at six months relative to baseline
Difficulties in Emotion regulation will be evaluated by the Emotion Regulation Scale (ERS) validated in Chile.
The Emotion Regulation Scale assesses emotions with respect to control, rejection, inattention, interference, and confusion.
ERS scale consists of 28 items with a Likert-type response options from 1 to 5 points, the scores range from 0 to 140 points and greater scores indicate worse emotional regulation.
Measured: Six months after admission to depression treatment
Therapeutic adherence at three months
Adherence to treatment will be evaluated by the Scale of Adherence to General Health Treatment validated in Chile.
The scale of Adherence consists of 21 questions with a Likert scale whose response options range from 1 to 6 points adding up to a total score from 22 to 132, lesser score means worst therapeutic adherence.
Measured: Three months after admission to depression treatment
Therapeutic adherence at six months
Adherence to treatment will be evaluated by the Scale of Adherence to General Health Treatment validated in Chile.
The Scale of Adherence consists of 21 questions with a Likert scale whose response options range from 1 to 6 points adding up to a total score from 22 to 132, lesser score means worst therapeutic adherence.
Measured: Six months after admission to depression treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start1 Dec 2021 (estimated)
- Primary completion30 Sep 2022 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The collaborative multidimensional model (CMD) for depression incorporates to the current knowledge for the treatment of depression in primary care (PHC) teams in Chile, competences for the management of clinical, functional, psycho-biographical dimensions. These dimensions are prevalent in patients consulting PHC in Chile, associated to a complex depression sub-type, for which the current clinical guide does not provide recommendations. The implementation of this model entails a 22-hour training consisting of lectures and workshops through a virtual platform, followed by the application of the CMD in the PHC teams. In brief, the application of the model involves the creation of a case manager that prioritizes participants according to their complexity and collaboration sessions with the participation of specialists and the PHC team every 15 days for at least 3 months after the training.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 394 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Talca
- Sponsor type
- University, hospital or other
- Collaborators
- National Fund for Research and Development in Health, Chile
- Responsible party
- Sponsor
- Investigators
- Veronica G Vitriol, MD, Study director, University of TalcaAlfredo A Cancino, MD, Study director, University of TalcaMaria L Aylwin, PhD, Principal investigator, University of Talca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05016388
- Sponsor's protocol ID
- SA20I0031
- Acronym
- CMID
- Status last verified
- Jun 2021
- First submitted
- 30 Jul 2021
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The sharing of the IPD data requires the authorization of the Ethics committee of the Universidad de Talca. The Study protocol, Statistical Analysis Plan, Informed Consent, Clinical Study Report and Analytic code will be included in future publications.
Publications
Saldivia S, Aslan J, Cova F, Vicente B, Inostroza C, Rincon P. [Psychometric characteristics of the Patient Health Questionnaire (PHQ-9)]. Rev Med Chil. 2019;147(1):53-60. doi: 10.4067/S0034-98872019000100053. Spanish.
PubMed 30848765Clavijo M, Yevenes F, Gallardo I, Contreras AM, Santos C. [The general self-efficacy scale (GSES): Reevaluation of its reliability and validity evidence in Chile]. Rev Med Chil. 2020 Oct;148(10):1452-1460. doi: 10.4067/S0034-98872020001001452. Spanish.
PubMed 33844715von Bergen, A., & de la Parra, G. (2002). OQ-45.2, Cuestionario para evaluación de resultados y evolución en psicoterapia: Adaptación, validación e indicaciones para su aplicación e interpretación [OQ-45.2, An Outcome Questionnaire for Monitoring Change In Psychotherapy: Adaptation, Validation and Indications for its Application and Interpretation]. Terapia Psicológica, 20(2), 161-176.
Garcia-Campayo J, Zamorano E, Ruiz MA, Pardo A, Perez-Paramo M, Lopez-Gomez V, Freire O, Rejas J. Cultural adaptation into Spanish of the generalized anxiety disorder-7 (GAD-7) scale as a screening tool. Health Qual Life Outcomes. 2010 Jan 20;8:8. doi: 10.1186/1477-7525-8-8.
PubMed 20089179Guzman-Gonzalez M, Mendoza-Llanos R, Garrido-Rojas L, Barrientos J, Urzua A. [Cut-off points of the difficulties in Emotion Regulation Scale for the Chilean population]. Rev Med Chil. 2020 May;148(5):644-652. doi: 10.4067/S0034-98872020000500644. Spanish.
PubMed 33399757Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57.
PubMed 9881538McAllister-Williams RH, Arango C, Blier P, Demyttenaere K, Falkai P, Gorwood P, Hopwood M, Javed A, Kasper S, Malhi GS, Soares JC, Vieta E, Young AH, Papadopoulos A, Rush AJ. The identification, assessment and management of difficult-to-treat depression: An international consensus statement. J Affect Disord. 2020 Apr 15;267:264-282. doi: 10.1016/j.jad.2020.02.023. Epub 2020 Feb 7.
PubMed 32217227Archer J, Bower P, Gilbody S, Lovell K, Richards D, Gask L, Dickens C, Coventry P. Collaborative care for depression and anxiety problems. Cochrane Database Syst Rev. 2012 Oct 17;10(10):CD006525. doi: 10.1002/14651858.CD006525.pub2.
PubMed 23076925Raja S, Hasnain M, Hoersch M, Gove-Yin S, Rajagopalan C. Trauma informed care in medicine: current knowledge and future research directions. Fam Community Health. 2015 Jul-Sep;38(3):216-26. doi: 10.1097/FCH.0000000000000071.
PubMed 26017000Vitriol V, Cancino A, Serrano C, Ballesteros S, Potthoff S. Remission in Depression and Associated Factors at Different Assessment Times in Primary Care in Chile. Clin Pract Epidemiol Ment Health. 2018 Mar 26;14:78-88. doi: 10.2174/1745017901814010078. eCollection 2018.
PubMed 29643931Vitriol V, Cancino A, Serrano C, Ballesteros S, Ormazabal M, Leiva-Bianchi M, Salgado C, Caceres C, Potthoff S, Orellana F, Asenjo A. Latent Class Analysis in Depression, Including Clinical and Functional Variables: Evidence of a Complex Depressive Subtype in Primary Care in Chile. Depress Res Treat. 2021 Feb 11;2021:6629403. doi: 10.1155/2021/6629403. eCollection 2021.
PubMed 33628499Salvo G L. [Magnitude, impact and recommended management strategies for depression, with reference to Chile]. Rev Med Chil. 2014 Sep;142(9):1157-64. doi: 10.4067/S0034-98872014000900010. Spanish.
PubMed 25517056Vitriol V, Cancino A, Sciolla A, Guinez S, Calvo J, Ormazabal M, Kreither J, Ballesteros S, Aylwin ML. Effectiveness of a multidimensional collaborative approach versus usual care in the treatment of adult depression in primary care in Chile: study protocol for a single blinded cluster randomized controlled trial. F1000Res. 2024 Oct 11;11:203. doi: 10.12688/f1000research.75764.2. eCollection 2022.
PubMed 39464248
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of a Multidimensional Collaborative Model to Improve the Resolution of Depression in Primary Care Teams in the Maule Region
- ClinicalTrials.gov ID
- NCT05016388
- Acronym / sponsor ID
- CMID / SA20I0031
- Conditions
- Depression
- Keywords
- Complex Depression, Collaborative Model, Primary Health Care, Trauma Informed Care, Difficult to treat Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 394 participants (estimated)
- Lead sponsor
- University of TalcaUniversity, hospital or other
- Collaborators
- National Fund for Research and Development in Health, Chile
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 23 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study protocol aims to determine the efficacy of a collaborative multidimensional model (CMD) to improve the results of depression in primary care (PHC) in Chile. The CMD includes training of PHC teams, on the recognition of clinical, functional and psycho-biographic dimensions associated to a complex depression sub-type, difficult to treat, prevalent in PHC in Chile, for which there are no recommendations in current clinical guidelines. This model implies the implementation of a collaborative model, trauma informed care, patient- centered, that includes a case manager, the use of instruments and a close relationship between the PHC team and the specialty level. At least twelve primary care teams belonging to the Maule Region will be randomly assigned to one of the two arms of the study, the CMD group and the current standard model (SM). After the implementation of the CMD, an intentional sample of 394 participants who agreed to participate, with prior informed consent, will be evaluated by a blind research team at the beginning, at three and six months with a battery of instruments. An improvement in depressive symptoms, anxiety and functional variables is expected in participants treated in CMD versus SM. This protocol was approved by the Research Ethics Council of the University of Talca, Talca. The goal is to publish the preliminary results in December 2022.
Detailed description
The research design is a cluster randomized clinical trial. Inter-professional teams from at least 12 primary care centers of the Maule area will be randomized in two arms: intervention and control. The intervention arm will receive a training in the collaborative multidimensional model for depression (CMD) and the control arm will be trained in the current clinical guide (SM).
After the CMD implementation, a sample of 394 participants entered to treatment for depression at their respective center will be invited to participate. This sample has been calculated estimating a maximum error of 5 %, a confidence level of 95 %, a power of 80 % a maximum variance of 50 % and a retention of 85 %.
The patients who agreed to participate, will be treated by their respective PHC team and their therapeutic indications will be included in the official clinical records for each participant. Also these patients, after informed consent, will be evaluated by a blind external research team at the beginning, at three and six months with a battery of instrument.
The informed consents will be kept in locked folders. The data obtained by the external evaluators will be confidential, entered into a virtual spreadsheet in a coded form on a server of the U. of Talca through a personal computer. Participant's diagnoses will be coded using the MINI.
A protocol for the management of adverse situations of an emergency nature will be provided.
The results will be presented according to the CONSORT guide for randomized clinical trials, with its extensions to cluster and non-pharmacological interventions.
Analysis of the primary and secondary outcomes will be performed by intention to treat. In the initial analysis, the balance between the characteristics of the different samples will be evaluated and a linear multi-variable regression will be performed to establish differences at 3 and 6 months, adjusting the results according to the initial data, in case of imbalance for all outcomes. A sensitivity analysis based on different assumptions will also be implemented, to investigate the possible effects of missing data. Statistical analysis will be done with SPSS software.
The research protocol was approved by the Ethics Committee of the University of Talca and approved by the Agencia Nacional de Investigación y Desarrollo (ANID), the national institution that audit the project through a follow-up sheet and yearly controls.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The collaborative multidimensional model (CMD) for depression incorporates to the current knowledge for the treatment of depression in primary care (PHC) teams in Chile, competences for the management of clinical, functional, psycho-biographical dimensions. These dimensions are prevalent in patients consulting PHC in Chile, associated to a complex depression sub-type, for which the current clinical guide does not provide recommendations. The implementation of this model entails a 22-hour training consisting of lectures and workshops through a virtual platform, followed by the application of the CMD in the PHC teams. In brief, the application of the model involves the creation of a case manager that prioritizes participants according to their complexity and collaboration sessions with the participation of specialists and the PHC team every 15 days for at least 3 months after the training.
| Arm | Type | Receives |
|---|---|---|
| Collaborative Multidimensional Model (CMD) | Experimental | Other: Collaborative Multidimensional Model (CMD)The teams in the CMD group will be composed each of at least a MD, a psychologist, and a social worker. The teams will receive the CMD training and the CMD will be installed in the primary health care (PHC) center. Then, the participants with depression who enter treatment for depression in their respective PHC center, will be enrolled and evaluated by an external team, blind to the interventions at the beginning, three and six months after. |
| Standard Model (SM) | Other | Other: Standard Model (SM)The teams in the SM group will be composed each of at least a MD, a psychologist, and a social worker. The teams will receive the SM training and the SM will be set in the primary health care (PHC) center. Then, the participants with depression who enter treatment for depression in their respective PHC center, will be enrolled and evaluated by an external team, blind to the interventions at the beginning, three and six months after. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Starting the treatment for depression in Primary Care according the Health Guarantees.
- Confirmed depression diagnosis according to the Mini International Diagnostic Interview Mini International Neuropsychiatric Interview (MINI, Sheehan et al. 1998).
Key exclusion criteria (6 listed)
- Sensory disability
- Inability to provide the informed consent
- not having contact phone number
- Continuing treatment for depression
- High suicidal risk
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collaborative Multidimensional Model (CMD)Also: InterventionThe teams enrolled in the CMD intervention will have a 22-hour training that integrates current knowledge of depression with skills for the management of functional variables, interpersonal, social, emotional regulation, and history of biographical adversity from childhood considering the trauma informed care paradigm. After the training, the PHC teams will implement the depression treatment according to a collaborative model. | Other | Collaborative Multidimensional Model (CMD) |
| Standard Model (SM)Also: ControlThe teams enrolled in the SM intervention will have a 22-hour training that integrates the current national clinical guide for Depression in Chile. This guide offers a staggered treatment according to the severity of the depression. After the training, the PHC teams will implement the depression treatment according to the SM. | Other | Standard Model (SM) |
Primary outcome
Change in Depressive symptoms at three months relative to baseline
Time frame: Three months after admission to depression treatment
Depressive symptoms will be assessed by the Patient Health Questionnaire (PhQ9). The Patient Health Questionnaire is a nine-item self-report measure that assesses the presence of depressive symptoms based on the DSM-IV criteria for major depressive. The Spanish version of the Patient Health Questionnaire has been validated in Chile. The Patient Health Questionnaire measures the symptoms experienced by the patients during the two weeks prior to the interview. Total score ranges from 0 to 27 points and greater scores means worse symptoms.
Change in Depressive symptoms at six months relative to baseline
Time frame: Six months after admission to depression treatment
Depressive symptoms will be assessed by the Patient Health Questionnaire (PhQ9). The Patient Health Questionnaire is a nine-item self-report measure that assesses the presence of depressive symptoms based on the DSM-IV criteria for major depressive. The Spanish version of the Patient Health Questionnaire has been validated in Chile. The Patient Health Questionnaire measures the symptoms experienced by the patients during the two weeks prior to the interview. Total score ranges from 0 to 27 points and greater scores means worse symptoms.
8 secondary outcomes
Change in Anxiety symptoms at three months relative to baseline
Time frame: Three months after admission to depression treatment
Change in Anxiety symptoms at six months relative to baseline
Time frame: Six months after admission to depression treatment
Change in Interpersonal Dysfunction and Social Dysfunction at three months relative to baseline
Time frame: Three months after admission to depression treatment
Change in Interpersonal Dysfunction and Social Dysfunction at six months relative to baseline
Time frame: Six months after admission to depression treatment
Change in Emotion Regulation at three months relative to baseline
Time frame: Three months after admission to depression treatment
Change in Emotion Regulation at six months relative to baseline
Time frame: Six months after admission to depression treatment
Therapeutic adherence at three months
Time frame: Three months after admission to depression treatment
Therapeutic adherence at six months
Time frame: Six months after admission to depression treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
- Background: PubMed 30848765Saldivia S, Aslan J, Cova F, Vicente B, Inostroza C, Rincon P. [Psychometric characteristics of the Patient Health Questionnaire (PHQ-9)]. Rev Med Chil. 2019;147(1):53-60. doi: 10.4067/S0034-98872019000100053. Spanish.
- Background: PubMed 33844715Clavijo M, Yevenes F, Gallardo I, Contreras AM, Santos C. [The general self-efficacy scale (GSES): Reevaluation of its reliability and validity evidence in Chile]. Rev Med Chil. 2020 Oct;148(10):1452-1460. doi: 10.4067/S0034-98872020001001452. Spanish.
- Backgroundvon Bergen, A., & de la Parra, G. (2002). OQ-45.2, Cuestionario para evaluación de resultados y evolución en psicoterapia: Adaptación, validación e indicaciones para su aplicación e interpretación [OQ-45.2, An Outcome Questionnaire for Monitoring Change In Psychotherapy: Adaptation, Validation and Indications for its Application and Interpretation]. Terapia Psicológica, 20(2), 161-176.
- Background: PubMed 20089179Garcia-Campayo J, Zamorano E, Ruiz MA, Pardo A, Perez-Paramo M, Lopez-Gomez V, Freire O, Rejas J. Cultural adaptation into Spanish of the generalized anxiety disorder-7 (GAD-7) scale as a screening tool. Health Qual Life Outcomes. 2010 Jan 20;8:8. doi: 10.1186/1477-7525-8-8.
- Background: PubMed 33399757Guzman-Gonzalez M, Mendoza-Llanos R, Garrido-Rojas L, Barrientos J, Urzua A. [Cut-off points of the difficulties in Emotion Regulation Scale for the Chilean population]. Rev Med Chil. 2020 May;148(5):644-652. doi: 10.4067/S0034-98872020000500644. Spanish.
- Background: PubMed 9881538Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57.
- Background: PubMed 32217227McAllister-Williams RH, Arango C, Blier P, Demyttenaere K, Falkai P, Gorwood P, Hopwood M, Javed A, Kasper S, Malhi GS, Soares JC, Vieta E, Young AH, Papadopoulos A, Rush AJ. The identification, assessment and management of difficult-to-treat depression: An international consensus statement. J Affect Disord. 2020 Apr 15;267:264-282. doi: 10.1016/j.jad.2020.02.023. Epub 2020 Feb 7.
- Background: PubMed 23076925Archer J, Bower P, Gilbody S, Lovell K, Richards D, Gask L, Dickens C, Coventry P. Collaborative care for depression and anxiety problems. Cochrane Database Syst Rev. 2012 Oct 17;10(10):CD006525. doi: 10.1002/14651858.CD006525.pub2.
- Background: PubMed 26017000Raja S, Hasnain M, Hoersch M, Gove-Yin S, Rajagopalan C. Trauma informed care in medicine: current knowledge and future research directions. Fam Community Health. 2015 Jul-Sep;38(3):216-26. doi: 10.1097/FCH.0000000000000071.
- Background: PubMed 29643931Vitriol V, Cancino A, Serrano C, Ballesteros S, Potthoff S. Remission in Depression and Associated Factors at Different Assessment Times in Primary Care in Chile. Clin Pract Epidemiol Ment Health. 2018 Mar 26;14:78-88. doi: 10.2174/1745017901814010078. eCollection 2018.
- Background: PubMed 33628499Vitriol V, Cancino A, Serrano C, Ballesteros S, Ormazabal M, Leiva-Bianchi M, Salgado C, Caceres C, Potthoff S, Orellana F, Asenjo A. Latent Class Analysis in Depression, Including Clinical and Functional Variables: Evidence of a Complex Depressive Subtype in Primary Care in Chile. Depress Res Treat. 2021 Feb 11;2021:6629403. doi: 10.1155/2021/6629403. eCollection 2021.
- Background: PubMed 25517056Salvo G L. [Magnitude, impact and recommended management strategies for depression, with reference to Chile]. Rev Med Chil. 2014 Sep;142(9):1157-64. doi: 10.4067/S0034-98872014000900010. Spanish.
- Individual participant dataSharing planned: Yes. The sharing of the IPD data requires the authorization of the Ethics committee of the Universidad de Talca. The Study protocol, Statistical Analysis Plan, Informed Consent, Clinical Study Report and Analytic code will be included in future publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veronica G Vitriol, MD study director
University of Talca
Alfredo A Cancino, MD study director
University of Talca
Maria L Aylwin, PhD principal investigator
University of Talca
Questions about this trial
What is this clinical trial studying?
A study testing Collaborative Multidimensional Model (CMD) and Standard Model (SM) in people with Depression, run by University of Talca.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria L Aylwin, PhD (56-98-239 1048, maaylwin@utalca.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Depressive symptoms at three months relative to baseline (time frame: Three months after admission to depression treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05016388, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2021.